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临床试验/NCT04536493
NCT04536493已完成4 期

Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair

Children's Hospital of Orange County1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年6月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
48
试验地点
1
主要终点
To compare pain scores

研究概览

简要总结

To compare pain scores during laceration repair with first suture placement using standardized visual analog scale (VAS) between 2 different topical local anesthetic application techniques for using LET gel. Specifically, the investigators are studying if applying LET gel 3 times, spaced 10 minutes apart (triple LET) provides superior anesthesia to one 30 minute application (single LET). Single LET is the current standard method of application.

详细描述

To compare pain scores during laceration repair with first suture placement using standardized visual analog scale (VAS) between 2 different topical local anesthetic application techniques for using LET gel. Specifically, the investigators are studying if applying LET gel 3 times, spaced 10 minutes apart (triple LET) provides superior anesthesia to one 30 minute application (single LET).

Secondary endpoints:

  1. To compare provider satisfaction scores using a Likert scale between the triple LET and single LET application techniques.
  2. To compare parental satisfaction scores using a Likert scale between the triple LET and single LET application techniques.
  3. To compare the need for additional local anesthetic infiltration between the triple LET and single LET application techniques.

Once patients are identified and consent is obtained, they will be randomized to one of two groups. One group will have LET gel applied to the laceration one time for a duration of 30 minutes. The other group will have LET gel applied 3 times, at 10 minute intervals. Between applications, the excess gel on the surface of the skin will be gently wiped off, and a new strip of LET gel will be applied. The laceration repair will proceed in a normal sterile fashion, using standard irrigation and debridement techniques. Laceration repair will occur within the 15 minutes following the 30 minute period of LET application to the wound. The patient will be asked to rate his/her pain immediately after the first suture is placed or attempted using the visual analogue scale (VAS, range 0-10). The decision to use any additional anesthetic infiltration will be left to the performing provider. There will be 2 nurses involved in the study. One nurse will be the patient's primary nurse and will be administering the LET gel (so will not be blinded, but will not be involved in data collection). The other nurse will be obtaining the VAS immediately (Appendix 3) after the first suture is placed, using a pre-prepared script (Appendix 3) and standardized technique. The nurse or research assistant will also be blinded as to the method of LET gel application. The provider performing the laceration repair will be blinded. The research assistant will not be blinded and will coordinate all involved providers and nurses, will ensure correct timing in LET gel administration, and laceration repair timing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Topical anesthetic applied by RN not involved in procedure.

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients with simple (< 3 cm) lacerations who are > 7 years old and < 18 years old, for whom the physician plans to close the laceration using simple superficial interrupted sutures.

排除标准

  • • Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears, or occurring over joints.
  • Patients who are developmentally delayed or have a disability preventing them from giving a reliable pain score.
  • Patients whose primary language is other than English or Spanish.
  • Patients for whom procedural sedation is required.
  • Patients receiving intranasal or oral midazolam or inhaled nitrous oxide.

研究组 & 干预措施

3 applications

Active Comparator

Patients receive 3 doses of LET

干预措施: LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications) (Drug)

1 application

Active Comparator

Patients receive single dose LET

干预措施: LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application) (Drug)

结局指标

主要结局

To compare pain scores

时间窗: The VAS to rate pain will be collected during laceration repair, immediately after the first suture placement or attempt. The VAS score is estimated to take up to 1 minute to collect. The VAS scale will be collected for each enrolled subject.

Visual Analog Scale (VAS) asks subjects to rate pain marking an X on a line between two ends: "No pain" (on the left) and "Pain as bad as it could possibly be" (on the right). The distance will be measured from "No pain" to the X placed by the subject. A higher measurement indicates more pain.

次要结局

  • To compare provider satisfaction scores(The provider satisfaction Likert scale will be collected immediately after the procedure.)
  • To compare parental satisfaction scores(The parental satisfaction Likert scale will be collected immediately after the procedure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Theodore Heyming

Physician; Emergency Department Medical Director

Children's Hospital of Orange County

研究点 (1)

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